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Impact of Exercise on Older Persons With Osteoarthritis
This study has been completed.
Study NCT00000434   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: January 21, 2000   Last Updated: December 20, 2007   History of Changes

January 21, 2000
December 20, 2007
December 1983
September 2003   (final data collection date for primary outcome measure)
Adherence to exercise [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00000434 on ClinicalTrials.gov Archive Site
Pain and stiffness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
 
Impact of Exercise on Older Persons With Osteoarthritis
Impact of Exercise on Older Persons With Osteoarthritis (OA)

Previous studies have found that exercise can reduce pain, improve endurance for physical activities, and improve cardiovascular fitness over time. However, these studies have not looked at the impact of exercise programs for older adults with osteoarthritis or at how long older adults continue exercising after a program is finished. This study will look at the long-term effects of a structured exercise program for people aged 60 or older who have osteoarthritis of the hip or knee. One goal of the exercise program is to encourage older people with osteoarthritis to continue exercising.

We will randomly assign study participants to either the exercise program or a control group that does not do the exercise program. We will monitor participants at the start of the study, at 8 weeks, and every 3 months for 2 years after the program is completed. The exercise program lasts for 8 weeks and includes an exercise part and an educational part led by trained physical therapists. We believe that participants in the treatment (exercise) group will show higher rates of continued exercise and higher functional status over time compared to the group of people who do not participate in the exercise program.

Recent exercise interventions have demonstrated statistically significant short-term improvements in muscle strength, fitness, and physical activity in people under the age of 70. This study seeks to determine if those same benefits can be achieved in an older population (mean age 84) with osteoarthritis of the hip or knee. The study will examine the long-term effects of a structured exercise program that seeks to promote adherence to continued exercise.

We will randomly assign people who meet the study criteria to the exercise intervention or control group. We will conduct measures at baseline, at 8 weeks, and at 3-month intervals for 2 years following the intervention. The exercise component of the intervention will include lower extremity muscle strengthening, range-of-motion exercises, and fitness walking. An educational component will focus on arthritis self-efficacy and perceived self-reported exercise efficacy. We hypothesize that treatment group participants will exhibit higher rates of adherence to exercise and higher functional status outcomes over time compared to controls.

Phase II
Interventional
Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Osteoarthritis
Behavioral: Fit and Strong!
Experimental: Fit and Strong! is a multi-component exercise and health education program that incorporates flexibility, aerobic conditioning, strength training, and group discussion/problem solving for lifestyle change.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
217
September 2003
September 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 60 years of age or older
  • Presence of osteoarthritis of the lower extremities with an American College of Rheumatology functional class rating of I, II, or III
  • No other contraindication from a personal physician for participation in the fitness walking
  • Lack of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire

Exclusion Criteria:

  • Under 60 years of age
  • Lack of osteoarthritis of the lower extremities
  • Contraindication from a personal physician for participation in fitness walking
  • Presence of moderate-to-severe cognitive impairment as assessed by the Short Portable Mental Status Questionnaire
  • Steroid injections in either hip or knee within the previous 6 months
  • Uncomplicated knee or hip surgery within previous year
  • Complicated knee or hip surgery within previous year
  • Plans for total knee or hip replacement within the next year
  • Rheumatoid arthritis or other systemic inflammatory arthritis
  • Diabetes that is not under control
  • Current participation in a structured aerobic exercise program
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000434
Susan Hughes, Center for Research on Health and Aging, UIC
P60 AR30692, NIAMS-050
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Aging (NIA)
Principal Investigator: Susan Hughes Center for Research on Health and Aging
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP